Orange Book product · Brand (NDA)
ANDROGEL
TESTOSTERONE
At a glance
Sep 07, 2012
Approved
Brand (NDA)
Application
AB2
TE code
8
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 07, 2012
14 yr ago
Today
Patent 8466136 expires
Listed drug product patent expiration.
Oct 12, 2026
in 4 mo
Patent 8466137 expires
Listed method-of-use patent (U-1103) expiration.
Oct 12, 2026
in 4 mo
Patent 8466138 expires
Listed method-of-use patent (U-1103) expiration.
Oct 12, 2026
in 4 mo
Patent 8486925 expires
Listed drug product patent expiration.
Oct 12, 2026
in 4 mo
Patent 8729057 expires
Listed drug product patent expiration.
Oct 12, 2026
in 4 mo
Patent 8741881 expires
Listed method-of-use patent (U-1103) expiration.
Oct 12, 2026
in 4 mo
Patent 8754070 expires
Listed drug product patent expiration.
Oct 12, 2026
in 4 mo
Patent 8759329 expires
Listed drug product patent expiration.
Oct 12, 2026
in 4 mo
Pharmaceutical detail
Active ingredient
TESTOSTERONE
Strength
1.62% (40.5MG/2.5GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
GEL
Route
TRANSDERMAL
TE code
AB2
Application
NDA 022309
Product number
003
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2014VOGELXOBrand (NDA)
NDA 204399 · UPSHER SMITH LABS
- 2014NATESTOBrand (NDA)
NDA 205488 · ACERUS
- 2013TESTOSTERONEBrand (NDA)
NDA 203098 · PERRIGO ISRAEL
- 2012TESTOSTERONEBrand (NDA)
NDA 202763 · ANI PHARMS
- 2011ANDRODERMBrand (NDA)
NDA 020489 · ABBVIE
- 2010FORTESTABrand (NDA)
NDA 021463 · ENDO OPERATIONS
- 2010AXIRONBrand (NDA)
NDA 022504 · ELI LILLY AND CO
- 2003ANDROGELBrand (NDA)
NDA 021015 · BESINS HLTHCARE
- 2003STRIANTBrand (NDA)
NDA 021543 · AUXILIUM PHARMS LLC
- 2002TESTIMBrand (NDA)
NDA 021454 · ENDO OPERATIONS
- 1997TESTODERM TTSBrand (NDA)
NDA 020791 · ALZA
- 1993TESTODERMBrand (NDA)
NDA 019762 · ALZA
Listed patents (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8466136 | Oct 12, 2026 | in 4 mo | Product |
| 8466137 | Oct 12, 2026 | in 4 mo | U-1103 |
| 8466138 | Oct 12, 2026 | in 4 mo | U-1103 |
| 8486925 | Oct 12, 2026 | in 4 mo | Product |
| 8729057 | Oct 12, 2026 | in 4 mo | Product |
| 8741881 | Oct 12, 2026 | in 4 mo | U-1103 |
| 8754070 | Oct 12, 2026 | in 4 mo | Product |
| 8759329 | Oct 12, 2026 | in 4 mo | Product |
